Trial · NCT01173679
Dasatinib With Fludarabine and Rituximab in Relapsed and Refractory CLL and SLL
NCT01173679, Phase 2, Terminated, Massachusetts General Hospital; results first posted 2017-03-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Dasatinib With Fludarabine and Rituximab in Relapsed and Refractory CLL and SLL. Trials, record NCT01173679. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01173679
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dasatinib With Fludarabine and Rituximab in Relapsed and Refractory CLL and SLL
- NCT number
- NCT01173679
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 10 participants, actual
- Lead sponsor
- Massachusetts General Hospital
- Conditions
- Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
- Interventions
- dasatinib, Rituximab, fludarabine
- First posted
- 2010-08-02
- Last updated
- 2017-04-14
- Results first posted
- 2017-03-20
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Response Rate | 2 years | To describe the response rate of complete response (CR) and partial response (PR) to treatment with this drug combination (SD=stable disease, PD=progressive disease) |
| Secondary | Progression-Free and Overall Survival | 2 years | To describe the progression-free and overall surivial |
| Secondary | Toxicities | 2 years | Dasatinib may enhance the myelosuppression expected from fludarabine. This toxicity will be monitored with frequent CBC's. If after Day 21 of a cycle there is a grade 4 cytopenia, a dose reduction will occur in the next cycle of treatment, and that cycle cannot start until the ANC \> 1,000 and the platelets \> 25,000. There is also a risk for pleural effusions with dasatinib, but the risk will be low, since there is a break from dasatinib dosing on days 15-28 of each cycle. Nevertheless, if a grade 2 pleural effusion occurs, there will be a dose reduction in the next cycle of treatment. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Response Rate | 2 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Progression-Free and Overall Survival | 2 years | months | MEDIAN | |
| SECONDARY | Toxicities | 2 years | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group38
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Response Rate | Dasatinib, Rituximab, Fludarabine | CR | 2 | Participants | |
| Response Rate | Dasatinib, Rituximab, Fludarabine | PR | 2 | Participants | |
| Response Rate | Dasatinib, Rituximab, Fludarabine | SD | 5 | Participants | |
| Response Rate | Dasatinib, Rituximab, Fludarabine | PD | 1 | Participants | |
| Progression-Free and Overall Survival | Dasatinib, Rituximab, Fludarabine | Progression-free survival | 8.75 | Inter-Quartile Range 2.75 to 13 | months |
| Progression-Free and Overall Survival | Dasatinib, Rituximab, Fludarabine | Overall survival | 24 | Inter-Quartile Range 16.25 to 24 | months |
| Toxicities | Dasatinib, Rituximab, Fludarabine | Platelets / 3 | 4 | Participants | |
| Toxicities | Dasatinib, Rituximab, Fludarabine | Platelets / 4 | 3 | Participants | |
| Toxicities | Dasatinib, Rituximab, Fludarabine | Platelets / 5 | 0 | Participants | |
| Toxicities | Dasatinib, Rituximab, Fludarabine | Platelets / Did not have any | 3 | Participants |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dasatinib, Rituximab, Fludarabine | 10 | |
| Overall Study | COMPLETED | Dasatinib, Rituximab, Fludarabine | 9 | |
| Overall Study | NOT COMPLETED | Dasatinib, Rituximab, Fludarabine | 1 |
Source ClinicalTrials.gov
Adverse events82
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Fatigue | General disorders | Dasatinib, Rituximab, Fludarabine | 5 | 10 | 18 |
| other | Anemia | Blood and lymphatic system disorders | Dasatinib, Rituximab, Fludarabine | 5 | 10 | 14 |
| other | Platelet count decreased | Investigations | Dasatinib, Rituximab, Fludarabine | 5 | 10 | 14 |
| other | Nausea | Gastrointestinal disorders | Dasatinib, Rituximab, Fludarabine | 5 | 10 | 7 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Dasatinib, Rituximab, Fludarabine | 4 | 10 | 12 |
| other | White blood cell decreased | Investigations | Dasatinib, Rituximab, Fludarabine | 4 | 10 | 11 |
| other | Blood bilirubin increased | Investigations | Dasatinib, Rituximab, Fludarabine | 4 | 10 | 9 |
| other | Dyspnea | Respiratory, thoracic and mediastinal disorders | Dasatinib, Rituximab, Fludarabine | 4 | 10 | 9 |
| other | Chills | General disorders | Dasatinib, Rituximab, Fludarabine | 4 | 10 | 8 |
| other | Hyperglycemia | Metabolism and nutrition disorders | Dasatinib, Rituximab, Fludarabine | 4 | 10 | 8 |
1 to 10 of 82Source ClinicalTrials.gov
See all 82 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dasatinib, Rituximab, Fludarabine | ||
| Total, other adverse events | Dasatinib, Rituximab, Fludarabine | 10 | 10 |
| Total, serious adverse events | Dasatinib, Rituximab, Fludarabine | 2 | 10 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01173679
GET https://conductscience.org/api/trials/v1/NCT01173679/results?page=2